1. Dr Reddy’s Lab gets USFDA warning letter for 3 drug plants

Dr Reddy’s Lab gets USFDA warning letter for 3 drug plants

Dr Reddy's Laboratories on Friday said it has received a warning letter from US health regulator over inadequate quality control procedures at its three drug manufacturing units in India.

By: | New Delhi | Updated: November 6, 2015 12:01 PM
Dr Reddy's

The letter was issued by the the United States Food and Drug Administration (USFDA) on Thursday for the Dr Reddy’s three manufacturing plants at Srikakulam, Miryalaguda and Duvvada (Photo: Reuters)

Drug firm Dr Reddy’s Laboratories on Friday said it has received a warning letter from US health regulator over inadequate quality control procedures at its three drug manufacturing units in India.

The letter was issued by the the United States Food and Drug Administration (USFDA) on Thursday for the three manufacturing plants at Srikakulam, Miryalaguda and Duvvada, the company said in a filing to BSE.

“Dr Reddy’s Laboratories today issued a statement acknowledging that it has received a warning letter issued by the USFDA dated November 5, 2015 relating to API manufacturing facilities at Srikakulam, Andhra Pradesh, and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh,” the filing said.

This action follows earlier inspections of these sites by the agency in November 2014, January and February 2015, respectively, it added.

“We take quality and compliance matters seriously and stand by our commitment to fully comply with cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated timeframe of 15 days.”

“We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes.”

The stock was trading at Rs 3,695.95 on BSE, down 13.09 per cent, at 1143 hours.

Get latest news and updates on Auto Expo 2018, check breaking news on Budget 2018, like us on Facebook and follow us on Twitter.

  1. No Comments.

Go to Top